Notified bodies are assessment organisations that have been named to handle conformity assessment tasks based on EU regulations. The assessment duties involve the placing of certain products on the market. These assessment bodies carry out duties specified in the product legislation for the specific product. EU legislation also determines whether a third party, i.e. a notified body, is required for assessing the conformity of a product. The competence of a notified body is primarily demonstrated with accreditation.
A notified body is an organisation declared by a member state to the European Commission that has the right to perform conformity assessment duties. The naming of notified bodies and the designating authority are laid down in law. The designating authority is responsible for the entry of the information of the notified bodies in the Nando (New Approach Notified and Designated Organisations) Information System maintained by the European Commission. The authority uses accreditation by FINAS when naming the notified bodies.
A notified body must complete one or several modules of the conformity assessment. The conformity assessment procedures are divided into modules with different technical methods. Accreditation is defined based on the modules covered by the body's operations. “Primary standards" have also been specified for the modules in EA's mandatory guideline EA-2/17, according to which the accreditation is sought. According to this, a notified body can be an accredited testing laboratory, an inspection body or a certification body.
The assessments also take into account the horizontal Act on notified bodies, 278/2016, and the national act on the industry.
Requirements and guidelines (updated 13th of November 2020)
The accreditation requirement for notified bodies is one of the following accreditation requirements:
SFS-EN ISO/IEC 17020:2012, SFS-EN ISO/IEC 17021-1:2015, SFS-EN ISO/IEC 17024:2012, SFS-EN ISO/IEC 17025:2017, SFS-EN ISO/IEC 17065:2012
The accreditation of notified bodies is also subject to the mandatory and regular guidelines of the field of accreditation in question. For more information, see the presentation page for each field of accreditation.
Mandatory guidelines relating to accreditation of notified bodies